Seal for a connector of a movable catheter system

ABSTRACT

A slip seal adapter is for insertion within a connector of movable catheter components. The adapter includes a rigid tube and a thermally shrinkable wrap extending from the tube. A lumen runs through the adapter to permit the catheter to pass through the connector and through the adapter lumen, whereby the shrinkable wrap sealably surrounds a portion of the catheter. The shrinkable wrap comprises a lubricious material that permits the enclosed catheter to move in a lateral and/or rotational direction and yet maintains the close contact with the catheter.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority from U.S. Provisional PatentApplication No. 60/453,846, filed Mar. 10, 2003, the content of which isincorporated herein by reference in its entirety.

FIELD OF THE INVENTION

[0002] The present invention relates to a seal for a catheter system ofa medical device. The present invention is particularly useful forsealing a catheter connection and allowing the catheter to move relativeto the connector. It is to be understood that the terms “medical device”and “medical field”, as used herein, include traditional medicine aswell as alternative medicines including chiropractic, acupuncture, etc.,as well as the veterinary field.

BACKGROUND OF THE INVENTION

[0003] In numerous applications of devices in the medical field, it maybe necessary or desirable to create a fluid-tight seal betweenstructural components of a catheter system. For many catheter-baseddevices, creating such as seal is manifestly critical to the safety andreliability of the devices. It is often important for medical devices toincorporate a mechanism to prevent liquid or gasses, including air, fromcontacting certain device elements, entering the body through thecatheter, seeping in, such as where suction pressure may be diluted, orleaking out of the device, such as where suction pressure may be lost.

[0004] An intracorporeal device that uses a catheter system may beemployed for therapeutic and/or diagnostic procedures. For example, adevice to remove obstructions, including partial or total occlusions orother lesions of various types, from a target site in the body, e.g. ablood vessel, is well established treatment modality in interventionalcardiology. Numerous methods and devices that employ catheters have beenconceived and developed. For example, catheter systems are widely usedin atherectomy or thrombectomy devices for the treatment of arterialocclusions and may be inserted within a patient at various sites on orin the body. Atherosclerosis is a condition arising from the depositionof fat-like matter, i.e. plaque, on the walls of blood vessels. As aresult of accumulated obstructions, blood flow becomes restricted orblocked, creating health risks, including coronary artery disease,angina and heart attacks.

[0005] In general, catheters are tubular structures that may are used asa passageway into a body. Although the term, “catheter”, as used herein,is intended to include one or a combination of many types ofconventional catheters that are widely known in the medical field. Onetype of catheter, for example, is commonly referred to as a “guidingcatheter” and has a lumen and a distal orifice through which otherdevices such as guidewires, other catheters, and the like may be guidedand manipulated. Another type of catheter, referred to as an “operatingcatheter” herein, has a functional portion, i.e. “operating head”,generally at the distal tip, that is useful for gathering informationand/or performing a diagnostic or therapeutic function. Typically, theoperating head is translated or manipulated through the guiding catheterand to a target site in the body, where the operating head may beactivated. The operating catheter system may include various layers,lumens, connectors, bearings, and/or other devices that communicate withthe operating head. For example, the catheter system may include one ormore drive shaft(s), guidewire(s), catheter(s), protective sheath(s),optical fiber(s), cable(s), wire(s), etc. In some systems, a catheter isemployed to effectively isolate the rotating elements of the device,such as a drive shaft, from direct contact with any healthy body matter,e.g. tissue. Connection between various catheters and/or components isoften required.

[0006] A standard adapter, such as a Y-adapter, and/or a Touhy Borstvalve, consists of an open straight channel which accepts a guide wireand catheter, and an angled secondary channel that attaches to amanifold for pressure monitoring, contrast injection, flushing, etc.Such connectors of catheter components and associated joints in cathetersystems typically incorporate proximally a hand tightened valve, oftencalled a hemostatic valve, with a rubber O-ring or similar ring. It isdifficult to tighten a hemostatic valve to prevent leaks and stillprovide for low friction movement of the catheter or device the valveseals around. Frictional heating by an O-ring may also be destructive tothe seal. Moreover, an O-ring is typically molded and imperfect instructure.

[0007] Some Y-adapters use a self closing valve (such as Co-Pilot™Y-adapter available by Guidant Corporation, located in Indianapolis,Ind.) in conjuction with a rotating hemostatic valve. However, thisvalve also uses certain materials, such as silicon rubber or the like,that have relatively high coefficient of friction and require springforces to close such that motion of a catheter through the valve isslightly impeded. Thus, standard connectors do not efficiently permitmovement of the enclosed catheter.

[0008] It is further important that such joints between components aresealed in particular intracorporeal devices that force aspirationthrough the catheter to urge materials through the catheter. Foratherectomy or thrombectomy procedures, it has been found that steps tocollect dislodged particulates from accumulating in the body arecritical. For example, findings have shown that stent deployment totreat interventional treatment for acute coronary syndrome (ACS) isoften associated with plaque embolization in patients with ACS. SeeCirculation 2003; 107:2320-5. This heart damage increases the risk oflong-term adverse clinical outcomes. In another example, kidneys areknown to be very susceptible to blockage if embolisms occur in a renalartery during renal interventions. In the case of treatment of deep veinthrombosis, complications also occur if a clot breaks off and travels inthe bloodstream to the lungs.

[0009] Some current devices employ filter systems to catch looseneddebris. However, filter systems may allow small particles to pass andmay be poorly positioned against a vessel wall. Other current devicesuse aspiration as an effective means to remove via suction embolicparticulates that have been extracted from the body and provide embolicprotection. However, it is important for the aspiration to beconsistently maintained and at high rate. A tight seal must be providedbetween catheters and/or catheter components so that aspiration is notlost through cracks in the joint between device components. Moreover, aseal must prevent air from getting into the aspiration area andcompeting with aspiration for space. Further, it is particularlyimportant that the seal is maintained for applications that requireobtaining accurate blood pressure readings with the use of theintracorporeal device.

[0010] Some catheter systems do not require movement of the catheter,such as balloon devices. For applications that require movingcomponents, one particular connector is useful at the proximal end ofthe guide catheter to permit an operating catheter or guide wire to passthrough this guide connector and extend into the guide catheter.

[0011] It is therefore desirable to provide a fluid-tight seal atjunctions for various catheter system components that permits thecatheter components to move with low friction for precision manipulationof the catheter system. In particular, a connector that maintains afluid-tight seal while permitting the smooth sliding of components, suchas lateral translation, is needed for a catheter system. The seal shouldbe adaptable to be useful in by a variety of connector types. Thepresent invention fulfills these needs and provides further relatedadvantages.

SUMMARY OF THE INVENTION

[0012] A slip seal adapter is provided for insertion within a connectorof catheter components, to seal the catheter and permit the catheter tomove in a lateral and/or rotational direction. The adapter includes arigid tube that is sized for insertion within the connector and athermally shrinkable wrap extending from the tube at an extensionsection of the wrap. A lumen in the adapter receives a catheter thatpasses through a bore in the catheter. The extension section of theshrinkable wrap sealably surrounds a portion of the catheter. Theshrinkable wrap comprises a lubricious material that permits slip of thecatheter and yet maintains the seal.

[0013] Although the adapter may be inserted in the connector in variousways, in one embodiment the distal portion of the tube is insertablewithin the connector and the extension section extends from the distalportion of the tube. A tightening segment of the connector, e.g. a TouhyBorst valve, securely clenches the tube. At times, the connector is a Yadapter that comprises at least one side port for passage of materialinto or from the catheter. For example, the connector may be provided toconnect an operating catheter system with a guiding catheter.

[0014] A portion of the shrinkable wrap covers the tube and isshrinkable to a first diameter that is at least substantially thediameter of the tube and the extension section is shrinkable to adiameter that is at least substantially the diameter of the catheter.The shrinkable wrap may comprise PTFE, Teflon®, FEP or PFA.

[0015] The adapter and connector is useful in various intracorporealmedical devices. One such device comprises an operating head coupled toa distal end of a catheter system. The catheter system encloses a driveshaft which couples to a drive system to be rotated. The catheter systempasses through a bore in the connector and a lumen in the adapter. Theextension section of the shrinkable wrap allows the catheter to bemanipulated into and away from the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The present invention is illustrated by way of example in thefigures of the accompanying drawings and the figures are not intendedfor limitation, which figures are not intended to limit the presentinvention, and in which:

[0017]FIG. 1 is a schematic diagram of an external view of a slip sealadapter implemented in an intracorporeal medical device, according toone embodiment of the present invention;

[0018]FIGS. 2A and 2B are enlarged schematic diagrams of the slip sealadapter, according to one embodiment of the present invention, whereinFIG. 2A is an angled external view of one slip seal adapter and FIG. 2Bis an internal view of one slip seal adapter;

[0019]FIGS. 3A and 3B are enlarged schematic diagrams of external viewsof a catheter connector system having a slip seal adapter and aconnector at a catheter junction, wherein FIG. 3A shows componentsexploded from the junction, and FIG. 3B shows a Y adapter with a TouhyBorst valve and a slip-seal adapter according to one embodiment of thepresent invention;

[0020]FIG. 4 is an enlarged schematic diagram of internal views of acatheter connector system including a slip seal adapter inserted into aconnector at a catheter junction; and

[0021]FIG. 5 is a perspective diagram illustrating one intracorporealmedical device that may incorporate the present slip seal adapter.

DETAILED DESCRIPTION OF THE INVENTION

[0022] A slip seal adapter is provided for insertion within a connectorof catheter components, in which at least one of the catheter componentsmay be moveable relative to the connector. The system comprising theadapter inserted within the connector is referred to herein as“connector system.” The adapter includes a rigid tube and a thermallyshrinkable wrap extending from the tube. A lumen runs through theadapter to permit the catheter to pass through the connector and throughthe adapter lumen, whereby the shrinkable wrap sealably surrounds aportion of the catheter. The shrinkable wrap comprises a lubriciousmaterial that permits the enclosed catheter to move in a lateral and/orrotational direction and yet maintains the close contact with thecatheter.

[0023] As shown by example in FIG. 1, one particular medical device 2that may incorporate a slip seal adapter 6 of the present invention isan intracorporeal medical device having a catheter system extending froma drive system to inside of a patient's body. The medical deviceincludes components that are inserted and navigated within the patient'sbody while an operator uses the medical device, and these components aregenerally continuous with and/or in communication with components forplacement external to the patient.

[0024] As used herein to describe various components of the medicaldevice including the sealing assembly affixed to the medical device, theterm “proximal” refers to a direction or area away from the end of thedevice to be first inserted into a body, and “distal” refers to thedirection or area toward such insertion portion.

[0025] In this particular example of a connector system, theextracorporeal components of the medical device 2 essentially comprise aguiding catheter 8 that is inserted into the body 12 at an insertionpoint 14. The guiding catheter terminates at its proximal end at theconnector 4. The slip seal adapter 6 is inserted within the connector 4at the connector's proximal end. A catheter 10 that surrounds a driveshaft passes through the guiding catheter and through the connector 4 toa drive system 16. The drive system rotates the drive shaft and may beany means of manually, such as by hand, or automatically rotating thedrive shaft, such as a motor, e.g. a high-speed electric motor or apneumatic-powered motor.

[0026] The drive shaft may be any elongated tube that is rotatable.Oftentimes, the drive shaft is a flexible, hollow, helical,torque-transmitting shaft. A multi-filar stainless steel coil driveshaft having a bi- tri- or quad-filar construction is often employed. Acoil drive shaft having an inner diameter of from about 0.015 to 0.025inch and an outer diameter of from about 0.025 to 0.035 inch is typicalfor atherectomy applications. In some applications, the drive shaft maybe rotated at high speeds of about 500 rpm to 200,000 rpm may be used,more typically about 10,000 to 100,000 rpm and more often about 40,000rpm, or more.

[0027] The connector having a slip seal adapter may be positioned atvarious locations along the length of the catheter system that isexternal to the body. Along the length of the catheter system there maybe one or more connectors that may link various layers and components ofthe catheter system. Typically, the connector system, i.e. the connectorand inserted adapter, is positioned at the proximal end of the guidingcatheter, where it is desirable to hold the guiding catheter stationarywhile sliding the catheter to and from the body.

[0028]FIGS. 2A and 2B show views of one embodiment of the slip sealadapter. The external view of the adapter 50 as depicted by FIG. 2Agenerally includes a rigid tube 52, a thermally shrinkable wrap 54 and alumen 58 extending through the tube and wrap. The slip seal adapter maybe any convenient length that fits within and may be secured by theconnector, such as about 1.0 inch to 2.0 inches in length.

[0029] One embodiment further includes an optional handle 56 to make foreasier handling of the adapter. The handle may be provided in anyconvenient location that which assists insertion of the adapter into theconnector. Typically the handle is positioned at the proximal end of theadapter and includes the lumen.

[0030] A portion of the adapter is an insertion segment 60 capable offitting within a connector and includes at least a portion of the tubeand the shrinkable wrap. As shown in FIG. 2B, a portion of the tube 52may be positioned inside of the handle 56. In one embodiment, theinsertion segment 60 includes the entire length of the tube 52 that isexternal to the handle 56. However, the insertion segment may alsoextend from the wrap to any shorter portion of the tube external to thehandle.

[0031] The tube comprises a rigid material, such as steel. The tube maybe any convenient length and diameter that fits within the connector,such as 1.0 to 2.0 inches long and less than 0.110 of the outer diameterand more typically between about 0.110 and 0.080 inch. The wall of thetube is often about 0.002 to 0.006 inch. It is usually desirable toprovide sufficient clearance between the catheter and the tube so thatthere is very little or no friction at the hemostatic seal.

[0032] The thermally shrinkable wrap 54 attaches to the tube and alsoincludes an extension section 62 that extends from the tube to wraparound a portion of the catheter. The extension section is capable ofadhering to the catheter to create a seal and permitting the catheter toslip within the wrap. The length of the extension segment is sufficientto permit seal and slip of the underlying catheter. In one embodiment,the extension section of the wrap is about 0.10 inch in length.

[0033] The wrap is attached to the tube by shrinking the wrap over theexterior surface of the tube. The wrap may cover the entire length ofthe tube or any portion thereof, such that the wrap is securely attachedto the tube. In one embodiment, the wrap covers the portion of the tubethat is clamped by the connector, such that the connector clamps ontothe wrap as well as the tube. In this manner, there is no interruptionof the outer adapter surface between the seal of the catheter by theextension section and the hemostatic seal of the connector to theadapter.

[0034] At least the extension section of the wrap, and typically theentire wrap comprises Teflon® (by e.i. DuPont De Nemours and CompanyCorporation located in Wilmington, Del.), or other similar lubriciousmaterial comprising the slip seal adapter permits smooth slipping of thecatheter within the extension section, yet the adapter provides aneffective seal against the catheter. The types of heat shrink materialmay also include, but not limited to, polytetrafluorothylene (PFTE)polymer, FEP, PFA, etc. In many applications it is desirable to use highthermal resistant material that melts at higher temperatures, such asPTFE, which melts at about 650 degrees F., whereas FEP melts at between400 to 500 deg. F. The sheath is very thin, such as 0.001 to 0.002 inch.

[0035] The lumen 58 allows the catheter to pass through the adapter 50.The lumen is larger than the diameter of the catheter and typicallyslightly larger. For instance, where a 0.075 inch catheter is usedwithin the adapter, the lumen may be between about 0.090 to 0.100 inchin diameter.

[0036] As shown in FIG. 3A, the slip seal adapter 100 is easilyinsertable within the connector 102. Typically, the adapter is be fittedat one or both ends of the connector. In one embodiment, the adapter 100is inserted at one end of the connector 102, such as the proximal end,and the terminal end of an outer catheter 104, such as the terminalproximal end of a guiding catheter, is inserted into the opposite end ofthe connector, such as the distal end. The insertion portion is insertedinto an opening 118 at the connector, such as the proximal end of theconnector. The diameter of the insertion section measures smaller thanthe diameter of the opening 118 such that the tube fits snuggly withinthe connector. As illustrated in FIG. 3B, in one embodiment, the handle106 of the slip seal adapter 100 may remain external to the connector102 after insertion.

[0037] Although the figures show essentially one way that the slip sealadapter associates with the connector, other configurations of theadapter with the connector are possible and intended to be within thescope of the present invention, whereby the connector clamps around thetube to form a seal. For example, in another embodiment, the adaptertube is inserted into the proximal opening of the connector and theextension section of the shrinkable wrap covers the catheter externallyfrom the connector. In this particular insertion configuration, theextension section of the wrap is positioned proximal to the tube of theadapter, rather than distal to the tube as shown in the example of FIG.3B.

[0038] The connector 102 may be any suitable connecting element thatseals a catheter from fluid leakage, such as at the terminal end of anouter catheter or at a joint between two ends of two catheters. Theconnector includes a tightening section 112, such as a snap-seal. Thepresent slip seal adapter is easily employed with several conventionalconnectors known in the art. Some typical connectors include aY-adapter, Touhy Borst valve, etc.

[0039] The connector 102, such as a Y-adapter for example, may also haveone or more side port 110 from a main tube 116. The side port is forinfusion of substances, such as drugs and/or injecting contrast to viewthe target site for the catheter in making certain that the catheter isits proper position. The port 110 of the connector may also be used forfluid extraction, such as taking a blood sample to measure the rate ofblood clots and. In one embodiment, the connector 102 is a Y-adapterhaving may be a tightening segment 112 that is a Touhy Borst rotatinghemostatic valve.

[0040]FIG. 4A and the enlarged view of Detail F shown in FIG. 4B showthe connector 202 clamped around the slip seal adapter 200 to form ahemostatic seal at a junction located at the proximal end of a guidingcatheter 208. The extension section 204 of the shrinkable wrap partiallycovers the tube 206 and partially covers the catheter 210 to create asmooth and slippable seal between the catheter 210 and the bore 212 ofthe connector the without allowing fluid leakage. Whereas the shrinkablewrap portion that surrounds the tube is shrunk to a first diameter, theextension section of the slip seal adapter is shrunk to a seconddiameter that is substantially or equal to the diameter of the catheterthat is to be inserted into the connector system. By the wrap shrinkingto at least substantially the diameter of the catheter, a precise fluidtight seal is formed, which creates little translational friction. Theextension section snuggly covers a portion of the catheter. The slipseal adapter of the present invention when used with a Touhy Borst valvemay withstand very high pressure, such as at least 40 psi.

[0041] The catheter 210 may further contains a drive shaft 220 and/orguide wire. At times, the catheter may include a wired support element222, such as a contiguous spiral coil, braid and/or weave of wire orribbon. The catheter 210 passes from the distal end 224 of the connectorand through the bore 212 of the connector to the proximal end 226 of theslip seal adapter 200. The proximal end of the slip seal adapter maycomprise a handle 214 that remains external to the connector.

[0042] The slip seal adapter allows the catheter to laterally translatetoward and away from the patient. During the removal operation, it isoften necessary to direct the operating head that is attached to thedistal end of the catheter, back and forth (i.e. laterally translate).The operator may create this movement by pushing and/or pulling at theproximal end of the catheter. The slip seal adapter create very littleor no friction during such lateral translation of the catheter againstthe adapter in the connector.

[0043] A wide variety of operating heads coupled to the distal end ofthe catheter for diagnostic or therapeutic surgical procedures within abody cavity is well known to those skilled in the art. For example,types of operating head may include a cutting head having one or morecutting surfaces, such as a rotary cutter with one or more blades orabrasives; a heating element for performing thermal ablation; electrodesfor performing electrosurgical cutting and cauterization; abrasiveelements for performing mechanical ablation; fluid jet stream tip;optical waveguides for performing laser ablation; ultrasonic transducersfor imaging and ablation; angioscopic imaging devices; and the like. Amore detailed description an exemplary operating head and intracorporealmedical device in which the connector system of the present inventionmay be used is provided in U.S. Pat. No. 6,565,588 B1, filed on Nov. 28,2000, the contents of which is incorporated herein by reference.

[0044] One example of a medical device that may employ the connectorsystem is useful in diagnosis and includes a probing operating head,such as an ultrasonic transducer. The diagnostic device may be useful inseveral medical fields. For example, in cardiology the operating headmay be used to inspect the inside of the heart to identify abnormalstructures or functions. The device may also be useful in measuringblood flow through the heart and other vessels. In urology, the devicemay be used to see kidney stones, measure blood flow through the kidney,detecting prostate cancer, etc.

[0045]FIG. 5 depicts one exemplary embodiment of the intracorporealmedical device 300 that may employ the connector system of the presentinvention. A catheter system 302 that comprises an operating head at adistal end and a power source, e.g. drive system, at a proximal end, isprovided. The catheter system may be inserted within a connector systemof the present invention to join with other device components. In oneembodiment, the slip seal adapter is strung over the length of thecatheter and is available for insertion into any connector.

[0046] A tubing system 304 extends from a hand held unit 306, e.g.tracking pod, to a receiving container 308 that collects fluid and/orparticles flowing from the catheter system. The tracking pod may housethe drive system, one or more connectors, system controls, etc. Aninfusate source 310 may also be provided to release fluid into thecatheter system, when desired. At the proximal location of the medicaldevice, a console unit 312 may further be provided to receive controlinformation from an operator and/or present operation information to theoperator. The console unit 312 may also provide a power source for themotor and an aspiration source. One or more pump(s) 314 may also beprovided to provide aspiration for drawing materials from the cathetersystem and to receiving container 308. In one embodiment, console unit312 and pump 314 are provided as a re-usable unit. In anotherembodiment, the hand held tracking pod 306 and control buttons may alsobe provided as a reusable unit. The catheter system often includesmultiple layers of components such as a drive shaft, one or moresheaths, optional guidewire, etc.

[0047] The present invention has been described above in varied detailby reference to particular embodiments and figures. However, thesespecifics should not be construed as limitations on the scope of theinvention, but merely as illustrations of some of the presentembodiments. It is to be further understood that other modifications orsubstitutions may be made to the described connector and slip sealadapter. For example the connector and adapter may be useful to create amoveable seal for numerous different types of catheters. Furthermore,the slip seal adapter is intended to be functional with a variety ofconnectors that may clamp around a rigid member, e.g. tube, of theadapter. The specific examples provided are not intended to limit thetypes of catheters and connectors used with the adapter that are knownor will be determined in the future.

We claim:
 1. An adapter for a catheter connector, the adaptercomprising: a rigid tube for insertion into the connector; a lumen sizedto permit a catheter that passes through the connector to also passthrough the lumen; and a thermally shrinkable wrap extending from thetube to form an extension section, wherein the extension section isshrinkable to surround a portion of the catheter and to permit thecatheter to move in a lateral and/or rotational direction.
 2. Theadapter of claim 1, wherein the tube has a distal portion that isinsertable within the connector and wherein the extension sectionextends from the distal portion of the tube.
 3. The adapter of claim 2,wherein the tube is sized to be securely clenched by a tighteningsegment of the connector.
 4. The adapter of claim 3, wherein thetightening segment is a Touhy Borst valve.
 5. The adapter of claim 1,wherein the connector is a Y adapter comprises at least one side portfor passage of material into or from the catheter.
 6. The adapter ofclaim 1, wherein a portion of the shrinkable wrap covers the tube and isshrinkable to a first diameter that is at least substantially thediameter of the tube and the extension section is shrinkable to adiameter that is at least substantially the diameter of the catheter. 7.The adapter of claim 1, wherein the shrinkable wrap comprises PTFE,Teflon®, FEP or PFA.
 8. A catheter connector system comprising: aconnector having a bore, and an adapter inserted in the connector, theadapter comprising: a rigid tube for insertion into the connector; alumen sized to permit a catheter that passes through the bore of theconnector to also pass through the lumen; and a thermally shrinkablewrap extending from the tube to form an extension section, wherein theextension section is shrinkable to surround a portion of the catheterand to permit the catheter to move in a lateral and/or rotationaldirection.
 9. The system of claim 8, wherein a distal portion of thetube is inserted within the connector and wherein the extension sectionextends from the distal portion of the tube.
 10. The system of claim 8,wherein the connector includes a tightening segment to securely clenchthe tube of the adapter.
 11. The system of claim 10, wherein thetightening segment is a Touhy Borst valve.
 12. The system of claim 8,wherein the connector is a Y adapter comprises at least one side portfor passage of material into or from the catheter.
 13. The system ofclaim 8, wherein a portion of the shrinkable wrap covers the tube and isreduced to a first diameter that is at least substantially the diameterof the tube and the extension section is shrinkable to a diameter thatis at least substantially the diameter of the catheter.
 14. The adapterof claim 8, wherein the shrinkable wrap comprises PTFE, Teflon®, FEP orPFA.
 15. An intracorporeal medical device comprising: a catheter system;an operating head coupled to a distal end of the catheter system; aconnector having a bore through which the catheter system passes; and anadapter inserted in the connector, the adapter comprising: a rigid tubefor insertion into the connector; a lumen sized to permit the cathetersystem that passes through the connector to also pass through the lumen;and a thermally shrinkable wrap extending from the tube to form anextension section, wherein the extension section surrounds a portion ofthe catheter system and permits the catheter system to move in a lateraland/or rotational direction.
 16. The system of claim 15, wherein theconnector includes a tightening segment to securely clench the tube ofthe adapter.
 17. The system of claim 15, wherein a portion of theshrinkable wrap covers the tube and is reduced to a first diameter thatis at least substantially the diameter of the tube and the extensionsection is reduced to a diameter that is at least substantially thediameter of the catheter.
 18. The adapter of claim 15, wherein theshrinkable wrap comprises PTFE, Teflon®, FEP or PFA.
 19. The device ofclaim 15, further comprising a drive shaft extending within the cathetersystem and a drive system to rotate the drive shaft.
 20. The device ofclaim 19, further comprising a control system to direct rotation of thedrive shaft.